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Evaluate the initial safety and effectiveness of Microburst VNS stimulation in subjects with refractory epilepsy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microburst Stimulation | Experimental | Microburst stimulation to tolerability and effectiveness |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microburst Stimulation | Device | Implantable generator with new stimulation feature under study to determine the safety and effectiveness of device stimulation on different seizure types. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy Primary Endpoint: Percent change from baseline in seizure frequency | For the primary endpoint, the change in the seizure frequency per month compared to baseline will be evaluated for each subject at follow-up visits month 6 and 12. | Up to 12 months study visit |
| Safety Primary Endpoint: Occurrence of stimulation related Adverse Events | Assess stimulation/device related adverse events at follow-up visits month 6 and 12. | Up to 12 months study visit |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in seizure frequency per month based on seizure diary provided by the sponsor | Up to 12 months study visit | |
| Change from baseline in seizure severity | As measured by the Seizure Severity Questionnaire (SSQ) scale (Cramer, 2002). |
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Inclusion Criteria:
4(A) For subjects with partial onset seizures: An average of ≥ 3 countable seizures per month based on seizure diary during the 3 month baseline period and no seizure-free interval greater than 30 days during those 3 months.
4(B) For subjects with PGTCs: Have at least ≥ 3 countable seizures during the 3 month baseline period. Note: Each seizure within a cluster may be counted as separate seizures.
5. 12 years of age or older.
6. Subject is a male or non-pregnant female adequately protected from conception. Females of childbearing potential must use an acceptable method of birth control.
7. Provide written informed consent-assent/Health Insurance Portability and Accountability Act (HIPAA) authorization and self-reported measures with minimal assistance as determined by the investigator.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Selim Benbadis, MD | University of South Florida Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| University of Denver Colorado |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38532258 | Derived | Szaflarski JP, Allendorfer JB, Begnaud J, Ranuzzi G, Shamshiri E, Verner R; Microburst Study Group. Optimized microburst VNS elicits fMRI responses beyond thalamic-specific response from standard VNS. Ann Clin Transl Neurol. 2024 May;11(5):1135-1147. doi: 10.1002/acn3.52029. Epub 2024 Mar 26. | |
| 38499287 | Derived |
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| ID | Term |
|---|---|
| D004828 | Epilepsies, Partial |
| D004830 | Epilepsy, Tonic-Clonic |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Two cohorts of subjects with refractory epilepsy; (1) subjects with primary generalized tonic-clonic seizures and (2) subjects with partial onset seizures including complex partial seizures with or without secondary generalization.
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| Up to 12 months study visit |
| Change from baseline in quality of life | As measured by the QOLIE-31-P for adults 18 years and older (Cramer et al.; 1998) and QOLIE-AD-48 for adolescents 12 to 17 years (Cramer et al.; 1999). | Up to 12 months study visit |
| Change from baseline in antiepileptic drug (AED) load | Estimated as the sum of the prescribed daily dose (PDD)/defined daily dose (DDD) ratios for each AED included in the treatment regimen (Deckers et al., 1997), where DDD (WHO ATC/DDD index) corresponds to the assumed average therapeutic daily dose of a drug used for its main indication. | Up to 12 months study visit |
| Suicidality as measured by the Columbia Suicide Severity Rating Scale (C-SSRS) | Up to 12 months study visit |
| All adverse events | Up to 12 months visit |
| Denver |
| Colorado |
| 80204 |
| United States |
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | United States |
| Rush University | Chicago | Illinois | 60612 | United States |
| Northwestern University | Evanston | Illinois | 60208 | United States |
| Weil-Cornell Medical College | Ithaca | New York | 10065 | United States |
| Duke University | Durham | North Carolina | 27708 | United States |
| University of Utah | Salt Lake City | Utah | 84112 | United States |
| Ghent University Hosptial | Ghent | Belgium |
| Drees C, Afra P, Verner R, Kaye L, Keith A, Jiang M, Szaflarski JP, Nichol K; Microburst Study Group. Feasibility study of microburst VNS therapy in drug-resistant focal and generalized epilepsy. Brain Stimul. 2024 Mar-Apr;17(2):382-391. doi: 10.1016/j.brs.2024.03.010. Epub 2024 Mar 16. |
| 37384278 | Derived | Verner R, Szaflarski JP, Allendorfer JB, Vonck K, Giannicola G; Microburst Study Group. Modulation of the thalamus by microburst vagus nerve stimulation: a feasibility study protocol. Front Neurol. 2023 Jun 13;14:1169161. doi: 10.3389/fneur.2023.1169161. eCollection 2023. |
| D004829 |
| Epilepsy, Generalized |